Clinical trial · Interventional
Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer
Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial
NCT07092696CI-TRIAL-00092795recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the efficacy and tolerability of a platinum-based regimen combined with the PD-1 antibody toripalimab administered prior to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic External-Beam Radiotherapy (EBRT) | Radiation | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 arm
- description
- Induction PD-1 inhibitor followed by PD-1 maintenance administered concurrently with chemoradiotherapy and continued after completion.
- interventionNames
- Drug: Toripalimab
- Radiation: Pelvic External-Beam Radiotherapy (EBRT)
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 1 year
- description
- The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Secondary outcomes (2)
- measure
- Disease Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18-75 years. * Histologically confirmed, previously untreated locally advanced cervical cancer of squamous, adenocarcinoma, or adenosquamous type. * At least one measurable lesion that has not received prior local therapy (non-nodal lesion ≥ 10 mm longest diameter or pathological lymph node ≥ 15 mm short axis, per RECIST 1.1). * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. * Estimated life expectancy ≥ 6 months. * Investigator-assessed eligibility for concurrent chemoradiotherapy. * No clinically significant active bleeding. * Laboratory values: WBC \> 4 × 10⁹/L; platelets \> 100 × 10⁹/L. * No history of other malignancies. * Women of child-bearing potential must have a negative serum pregnancy test and use effective contraception throughout the study. * Written informed consent obtained prior to any study-related procedures. Exclusion Criteria: * Tumor recurrence or distant metastasis at screening. * Active autoimmune disease requiring systemic therapy, or any chronic condition requiring long-term high-dose corticosteroids (≥10 mg/day prednisone or equivalent) or other immunosuppressive agents. * Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or any other immunosuppressive drugs within 14 days before first study dose or anticipated during the study. * Live-attenuated vaccination within 30 days before first dose or planned during the study. * Prior organ transplantation or known HIV infection. * Active hepatitis B (HBV DNA \>2000 IU/mL or \>10⁴ copies/mL, or HBsAg positive) or active hepatitis C (HCV RNA \>10³ copies/mL); co-infection with both viruses is also excluded. * Prior therapy with any agent targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4 (e.g., ipilimumab), or any other antibody or drug that modulates T-cell co-stimulation or checkpoint pathways. * Known hypersensitivity to monoclonal antibodies, fusion proteins, or any excipients in the investigational products. * History of another malignancy within the past 5 years, except adequately treated cervical carcinoma in situ, basal-cell carcinoma of the skin, or other localized malignancies considered cured. * Severe non-surgical comorbidity or acute infection. * Peripheral neuropathy \> Grade 1 (NCI-CTCAE). * Inadequate hematologic or organ function: * WBC \< 4.0 × 10⁹/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L, Hb \< 90 g/L * TBIL \> 1.5 × ULN, ALT/AST \> 2.5 × ULN, BUN \> 1.5 × ULN, creatinine \> 1.5 × ULN * Symptomatic brain metastases. * Clinically significant cardiac arrhythmias, myocardial ischemia, severe conduction block, heart failure, or severe valvular disease. * Severe bone-marrow failure. * Uncontrolled psychiatric illness. * Pregnant or lactating women. * Investigator-judged unsuitability for the trial. * Concurrent participation in another interventional clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.